FDA 483 - PremiumEStore LLC. dba Premium-PPE - September 17, 2024

PremiumEStore LLC, dba Premium-PPE, a manufacturer in Virginia Beach, VA, was cited for two significant observations during an FDA inspection. The firm failed to adequately establish and implement procedures for finished device acceptance, including proper documentation of inspection failures and verification of all product specifications. Additionally, the inspection revealed deficiencies in the firm's non-conformance procedures, with multiple non-conforming product issues lacking documented investigation, inspection, or disposition.